---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-198384"
form_type: "8-K"
ticker: "SPRY"
cik: "0001671858"
company_name: "ARS Pharmaceuticals, Inc."
filed_at: "2024-08-12T23:59:59+00:00"
generated_at: "2026-05-31T10:04:36.765601+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves ARS Pharma's neffy epinephrine nasal spray for allergic reactions

## Summary
- FDA approved neffy on Aug 9, 2024 for emergency treatment of anaphylaxis in adults and children ≥30 kg.
- Approval based on five registration studies showing pharmacokinetic/pharmacodynamic data within range of approved injectable epinephrine.
- neffy expected to be available in US within 8 weeks; plan to file sNDA for children 15-<30 kg by end of Q3 2024.
- CHMP positive opinion in EU on June 27; EMA decision expected Q3 2024; European commercial launch expected Q4 2024 via partner.

## SEC filing metadata
- accession: 0001193125-24-198384
- form_type: 8-K
- ticker: SPRY
- cik: 0001671858
- company_name: ARS Pharmaceuticals, Inc.
- filed_at: 2024-08-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1671858/000119312524198384/0001193125-24-198384-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671858/000119312524198384/d844683d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-198384
- JSON: https://secwatch.observer/filing/0001193125-24-198384.json
- Plain text: https://secwatch.observer/filing/0001193125-24-198384.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.